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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1101 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 1101

 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
  regulation of patient records and certain decision support software.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 27, 2015

  Mr. Bennet introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
  regulation of patient records and certain decision support software.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Electronic Data Technology 
Enhancement for Consumers' Health Act'' or the ``MEDTECH Act''.

SEC. 2. REGULATION OF MEDICAL SOFTWARE.

    Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j) is amended by adding at the end the following:
    ``(o) Regulation of Medical and Certain Decision Support 
Software.--
            ``(1) Exclusions from the category of devices.--The term 
        `device', as defined in section 201(h), shall not include the 
        following:
                    ``(A) Software that is intended for administrative 
                and operational support of a health care facility or 
                the processing and maintenance of financial records, 
                appointment schedules, business analytics, 
                communication, information about patient populations, 
                and laboratory workflow processes.
                    ``(B) Software that is intended for the purpose of 
                maintaining or encouraging a healthy lifestyle and are 
                unrelated to the diagnosis, cure, mitigation, 
                prevention, or treatment of a disease or disorder.
                    ``(C) Except for software intended to interpret or 
                analyze medical image data for the purpose of 
                diagnosis, cure, mitigation, prevention, or treatment 
                of a disease or condition, electronic patient records, 
                to the extent that such records are intended to 
                transfer, store, convert formats, or display the 
                equivalent of a paper medical chart, which may include 
                patient history records if--
                            ``(i) such records were created, stored, 
                        transferred, or reviewed by health care 
                        professionals, or by individuals working under 
                        supervision of such professionals; and
                            ``(ii) such records are part of health 
                        information technology that is certified under 
                        section 3001(c)(5) of the Public Health Service 
                        Act as being in compliance with applicable 
                        certification criteria adopted under subtitle A 
                        of title XXX of such Act.
                    ``(D) Except for software intended to interpret or 
                analyze clinical laboratory test data, software that is 
                intended to transfer, store, convert formats, or 
                display--
                            ``(i) clinical laboratory test report data, 
                        results, or findings prior to analysis or 
                        interpretation by a health care professional; 
                        or
                            ``(ii) clinical laboratory test report 
                        data, results, or findings, or related patient 
                        education information with respect to such 
                        data, to a patient.
                    ``(E) Except for a device accessory and software 
                that is intended to acquire, process, or analyze a 
                medical image or a signal from an in vitro diagnostic 
                device or a pattern or signal from a signal acquisition 
                system, software that--
                            ``(i) is intended to display, analyze, or 
                        print medical information about a patient or 
                        other medical information (such as peer-
                        reviewed clinical studies and clinical practice 
                        guidelines);
                            ``(ii) is intended to support or provide 
                        recommendations to a health care professional 
                        about prevention, diagnosis, or treatment; and
                            ``(iii) enables the health care 
                        professional to independently review the basis 
                        for each recommendation that the software 
                        presents such that it is not the intent that 
                        the health care professional rely solely on any 
                        specific recommendations or results provided by 
                        such software to make a clinical diagnosis or 
                        treatment decision.
            ``(2) Multiple functionality products.--In the case of a 
        product with multiple functionality that contains a software 
        function that is excluded under paragraph (1) from the 
        definition of a device under section 201(h) and a function that 
        meets the definition of device under section 201(h), the 
        Secretary shall not regulate the excluded software function of 
        the product as a device, but the Secretary may assess such 
        software function for the purpose of determining the safety and 
        effectiveness of the device function of the product.
            ``(3) Rules of construction.--Nothing in this subsection 
        shall be construed as limiting the authority of the Secretary 
        to--
                    ``(A) exercise enforcement discretion as to any 
                device subject to regulation under this Act; or
                    ``(B) regulate software devices used in the 
                manufacture and transfusion of blood and blood 
                components to assist in the prevention of disease in 
                humans.''.

SEC. 3. QUALITY AND STANDARDS.

    The Secretary of Health and Human Services shall ensure that 
software described in subparagraphs (C), (D), and (E) of subsection 
(o)(1) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j) (as amended by section 3) is consistent with appropriate 
quality principles and standards for software development and 
validation.

SEC. 4. CLASSIFICATION OF ACCESSORIES.

    Subsection 513(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360c(b)) is amended by adding at the end the following:
            ``(9) The Secretary shall classify an accessory under this 
        section based on the intended use of the accessory, 
        notwithstanding the classification of any other device with 
        which such accessory is intended to be used.''.

SEC. 5. CONFORMING AMENDMENT.

    Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(h)) is amended by adding at the end ``The term `device' does 
not include medical and decision support software described in section 
520(o).''.
                                 <all>
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